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FujiFilm EI-580BT Скачать руководство пользователя страница 106

202B1263075

<Image Size>

<Direction of Forceps>

<Medical Device Directive>

This product complies with the requirements of

European Directive 93/42/EEC.
Classification : Class II a

<Electromagnetic Compatibility (EMC) Information>

This product is intended for use in the electromagnetic environments specified below.
The customer or the user of this product should assure that it is used in such an environment.

Electromagnetic emission compliance information and guidance

Emission standard

Compliance

Guidance

RF emissions

CISPR 11

Group I

This product uses RF (Radio Frequency) energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electric equipment.

Radiated emissions

CISPR 11

Class A

This product is intended for use in medical
facilities and commercial facilities.
If this product is used in domestic establishments,
electromagnetic interference may occur on any
equipments.
In this case, it is recommended to use this
product according to “Chapter 1 Safety”.

Harmonic emissions

EN 61000-3-2

Class A

Voltage fluctuations/
flicker emissions

EN 61000-3-3

Applicable

[Note] Use in combination with the VP-4450HD video processor and XL-4450 light

source or with the VP-7000 video processor and BL-7000 light source.

FUJIFILM

FUJIFILM HP

FUJI TARO

106

Main Specification

EI580BT_E2-10_202B1263075.indb 106

2015/08/12 16:20:47

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Содержание EI-580BT

Страница 1: ...doscope and cautions to be observed when operating it Please read this manual thoroughly before actually operating the video endoscope After reading this manual store it nearby the video endoscope so...

Страница 2: ...202B1263075 2 EI580BT_E2 10_202B1263075 indb 2 2015 08 12 16 20 28...

Страница 3: ...this product be sure to read this manual before actual operation Also after reading this manual store it close to this product for future reference to keep the endoscope in optimum working condition I...

Страница 4: ...nctions and damages resulting from negligence of the precautions and operating methods contained in this manual 7 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from u...

Страница 5: ...T Reprocessing Manual as Reprocessing Manual How to Read This Manual Conventions Used in This Manual This manual uses the following conventions for easier understanding General Conventions Convention...

Страница 6: ...d system configuration Chapter 3 Preparation and Inspection Before Use This chapter describes the inspection and preparation methods to be performed for using the endoscope Chapter 4 Method of Use Thi...

Страница 7: ...1 1 6 Possible Combinations for Use 22 1 6 1 Accessories 22 1 6 2 Compatible Video Processor and Light Source 22 1 6 3 Peripheral Devices 23 1 7 Cautions Warnings 24 1 7 1 Abnormalities during Use of...

Страница 8: ...Attaching the Over tube 52 3 3 3 Mounting the Endoscope Balloon 52 3 3 4 Attaching the Fixing Rubber 54 3 3 5 Attaching the Hood Only When Necessary 57 3 3 6 Inspecting the Balloon 59 3 4 Connecting B...

Страница 9: ...ens or If the Image is Obscured 87 4 3 Treatment 88 4 4 Endoscope Withdrawal 89 4 5 Removing Hood Over tube and Balloon 91 4 5 1 Removing the Hood Only When Used 91 4 5 2 Removing the Balloon 92 4 5 3...

Страница 10: ...procedures This manual does not provide information about clinical procedures or any aspects of endoscopic techniques Do not modify this product or its components and do not disassemble repair or in...

Страница 11: ...nt infection Wear personal protective equipment when using the endoscope Otherwise it may cause infection When using this product for a patient with Creutzfeldt Jakob disease especially variant Creutz...

Страница 12: ...ening the lid If sterile gauze is not applied body fluid may be splattered leading to infection Be sure to attach a balloon and Over tube when using the endoscope If not attached body fluid may flow b...

Страница 13: ...loon and Over tube after use Used forceps valve balloon and Over tube could be a source of infection Use a cleaned and disinfected or sterilized air water valve and suction valve An inadequately clean...

Страница 14: ...ment with Electrosurgical Instruments WARNING When using diathermic treatment equipment maintain enough distance between the distal end of endoscope and the tip of the treatment equipment Energize the...

Страница 15: ...avoid adverse outcomes such as electric shock when this product is used in combination with other devices Prevent patient s body from touching electric conductor such as metal part of bed while using...

Страница 16: ...ndotherapy device to be pressed against the mucosal surfaces resulting in bleeding or perforation CAUTION During an observation do not perform close observation for an extended period of time Use the...

Страница 17: ...product that contains natural rubber as a material Natural rubber may rarely cause allergy symptoms such as itching reddening hives swelling fever dyspnea asthma like symptoms drop of blood pressure...

Страница 18: ...causing perforation Make sure that water never enters the balloon air feed inlet clear tube of the Over tube or the balloon air feed inlet of the endoscope Inflation or deflation of the balloon with...

Страница 19: ...devices that can be determined by turning the processor off and on we recommend that you may try to correct the interference by one or more of the following measures Change the orientation or positio...

Страница 20: ...elow The relevant safety signs are also described 1 5 1 Location of Labels Control Portion Model Label Instrument Channel Diameter Label LG Connector LG Connector Label Label for the Serial Number Lab...

Страница 21: ...ntative in the European Community Individual packaging bag for accessories Non sterile LG connector CE marking LG connector Degree of waterproof LG connector Type BF applied part LG connector WEEE mar...

Страница 22: ...to each operation manual of accessories CAUTION Do not press the hood against the digestive tract wall with undue force It may damage mucous membrane Fix the hood securely to the endoscope before use...

Страница 23: ...s of the peripheral devices used in combination with this product CAUTION For endoscopic CO2 regulators use only those designated by FUJIFILM If other devices are used the air water supply function ma...

Страница 24: ...itor Not doing so may cause damage to both the endoscope and body cavities of the patient Wear personal protective equipment when handling an endoscope to prevent infection and static charges When hol...

Страница 25: ...es subject to routine wear and tear Many factors can contribute to the reuse life of any instrument Besides clinical use routine handling as well as repeated cleaning and disinfection or sterilization...

Страница 26: ...ot use this product using maximum light intensity from the light source When this product projects light at the maximum brightness for 2 3 minutes temperature at the distal end may exceed 41 C If the...

Страница 27: ...202B1263075 27 Chapter 1 Precautions EI580BT_E2 10_202B1263075 indb 27 2015 08 12 16 20 31...

Страница 28: ...icate the number of articles Forceps Valve FOV DV7 10 Tube Kit TY 06S 1 Setting Tool for fixing rubbers ST 01B 1 Setting Tool for balloons ST 05B 20 Carrying Case 1 Manuals Operation Manual 1 Reproces...

Страница 29: ...ng Adapter CA 610 1 Air water channel cleaning adapter CA 611 1 Balloon Channel Cleaning Adapter CA 606 1 Injection Tube WA 007 Channel Plug WA 010 Balloon Channel Cleaning Adapter CA 606 1 Chapter 2...

Страница 30: ...through the instrument channel Recording video images Printing still images Sonoprobe System Endoscopic CO2 Regulator GW 1 GW 100 Endoscope EI 580BT Data Keyboard DK 4450E Video Processor VP 4450HD C...

Страница 31: ...urgical Unit Note 1 ICC 200 ERBE Note 1 For details refer to the manual of the electrosurgical instrument LCD monitor CDL1576A CDL1909A RADIANCE24 NDS Video Printer UP 51MD 120V 230V SONY UP 51MDU 120...

Страница 32: ...nt channel Recording video images Printing still images Sonoprobe System Endoscopic CO2 Regulator GW 1 GW 100 Endoscope EI 580BT Data Keyboard DK 7000U Video Processor VP 7000 Note 1 Cart Water Tank W...

Страница 33: ...The lift up kit is an optional accessory used to raise the position of the scope socket of the light source installed on the cart Electrosurgical Unit Note 3 ICC 200 ERBE VIO300D ERBE Note 3 For detai...

Страница 34: ...ight source Balloon Air Feed Inlet Connects to a syringe or the tube kit to supply air to or to remove air from the balloon attached to the distal end of the endoscope Air Supply Tube Supplies air fro...

Страница 35: ...The forceps valve consists of a valve body and a lid It performs the function of preventing leak or backflow of air Instrument Channel Inlet Inlet for passing forceps or endotherapy device through th...

Страница 36: ...from this outlet When air is removed from the balloon air feed inlet the air inside the balloon is take in from this outlet Air Water Nozzle This nozzle jets air or water onto the objective lens with...

Страница 37: ...ion and prevents leak or backflow of air when an endoscopic accessory such as an endotherapy device is used Lid This portion functions as a valve for preventing the leak or backflow of air How to Use...

Страница 38: ...onnector to feed air or fluid to the air water channel of the endoscope Tube for Instrument Suction Channel Connects to the suction channel Air Supply Tube Port Connects to the air supply tube of the...

Страница 39: ...el Inlet Cap Connects to the instrument channel inlet of the endoscope Plug Frame Connects to the valve on the endoscope s control portion How to Use Cleaning Adapter For details on how to use the cle...

Страница 40: ...a failure The bending section is operated by using up down left right angulation knobs Up down Angulation Knob Turn the up down angulation knob in the direction of U to angulate the bending section up...

Страница 41: ...tion knob in the direction of L to angulate the bending section to the left Turn it in the direction of R to angulate the bending section to the right R L R L Chapter 2 Product Overview 41 202B1263075...

Страница 42: ...n be operated either before or after operating the bending section Note When operating the bending section while the angle is locked angle knob rotation becomes heavy Up down Angulation Lock Move the...

Страница 43: ...e Free unlock Allows external force to angulate the bending section freely Rotate the knob in the direction opposite to F to lock the bending section Note Lock Maintains the angle of the bending secti...

Страница 44: ...s valve be attached to the instrument channel inlet 2 7 2 Air Water Valve To supply air cover the hole in the center of this valve with one s finger To supply water depress the valve while covering th...

Страница 45: ...the operation manual of the video processor When one switch is pressed the function assigned to it activates Scope Switches 4 Scope Switches 3 Scope Switches 2 Scope Switches 1 For details see the ope...

Страница 46: ...safety 3 1 Preparing Forceps Valve WARNING Ensure that the forceps valve is properly attached to the instrument channel inlet If this product is used without the forceps valve attached body fluid may...

Страница 47: ...nfecting or Sterilizing Forceps Valve 3 1 2 Inspecting the Forceps Valve The forceps valve is intended for single use If any abnormality is found do not use the product and use a new disinfected or st...

Страница 48: ...lve 3 2 1 Inspecting the Air Water Valve and Suction Valve Visually check that the valves are free from abnormalities such as foreign substances adhering to the valves tears distortions cracks indenta...

Страница 49: ...ve cylinder have a blue mark Note Manipulation method differs when a gas water valve provided with an endoscopic CO2 regulator is used For details on how to use refer to the operation manual of the en...

Страница 50: ...tube of the Over tube If water enters the air feed inlet deflate the balloon using a syringe and then slowly pull out the Over tube along with the endoscope 3 3 1 Preparing and Inspecting Necessary Eq...

Страница 51: ...setting tool and balloon setting tool according to the operation manual of the autoclaving unit Note The ST 01B fixing rubber setting tool or ST 10 and ST 05B balloon setting tool have not been steril...

Страница 52: ...check valve of Over tube into contact with the rubber cover of the endoscope Otherwise the backflow prevention function may be deteriorated 3 Feed air from the balloon air feed inlet several times to...

Страница 53: ...unt of 70 ethanol solution to the outside of the balloon setting tool ST 05B 4 Put the balloon on the balloon setting tool ST 05B 5 Insert the distal end of the endoscope into the balloon setting tool...

Страница 54: ...of the balloon Note Handle the balloon setting tool ST 05B without applying an excessive force to it 7 Extract the air in the balloon and remove the balloon setting tool ST 05B Note Dispose of the bal...

Страница 55: ...he balloon as in step 2 Note Carefully attach the fixing rubber so as not to cover the balloon air feed outlet When the ST 10 fixing rubber setting tool optional item is used Note For how to use the S...

Страница 56: ...nger into the fixing rubber Your finger may be caught in the fixing rubber 5 Insert the distal end of endoscope into the setting tool and then align the position of the fixing rubber with the balloon...

Страница 57: ...n is strongly scratched with the tip of the claw section the balloon may be damaged 3 3 5 Attaching the Hood Only When Necessary Attach a hood to hold the endoscope in an appropriate position for clos...

Страница 58: ...e fixing rubber onto the hood using the fixing rubber setting tool ST 01B Note Carefully attach the fixing rubber so as not to cover the balloon air feed outlet When the ST 10 fixing rubber setting to...

Страница 59: ...istal end of Over tube inflates 4 Remove air from the air feed inlet of the Over tube to make sure that the balloon deflates 5 Immerse the distal end of the endoscope into water and by feeding air fro...

Страница 60: ...onnected to the balloon controller PB 10 3 4 1 Connecting the Balloon Controller 1 Install the balloon controller referring to the operation manual of the balloon controller Connect the tube kit as fo...

Страница 61: ...side connector of the balloon controller is connected to the balloon air feed inlet of the endoscope and the OVERTUBE side connector of the balloon controller is connected to the air feed inlet of the...

Страница 62: ...controller to make sure that the balloon attached to the distal end of Over tube inflates 5 Press the switch again to make sure that the balloon deflates Chapter 3 Preparation and Inspection Before U...

Страница 63: ...stem 1 Move the cart with the video processor light source balloon controller and other peripherals to the place where endoscope is to be used Note Refer to the Installation Manual of the video proces...

Страница 64: ...r tank 80 filled with sterile water on the hook Note The water in the water tank should be changed at least daily using sterile water Note Use a cleaned and disinfected or sterilized water tank Collec...

Страница 65: ...ing part may cause damage to the eyes Immediately after removing the LG connector from the light source do not touch the light guide rod with hands since it is extremely hot There is a risk of burn in...

Страница 66: ...ed 1 Insert the LG connector into the scope socket of the light source until it stops Hold theLG connector with both hands align the index on the LG connector and the index on thelight source and then...

Страница 67: ...the endoscope 2 Insert the connector of the water tank to the water feed connector of the endoscope Align the groove on the connector and the pin of the water feed connector on the endoscope and atta...

Страница 68: ...e with both hands to make a semicircle with a diameter of approximately 200 mm referring to the figure at right Then move the apex of semicircle sliding insertion tube for full length Check that the t...

Страница 69: ...its neutral position 3 Turn the up down and left right angulation locks in the direction opposite to F and then lock them 4 Turn the angulation knobs in similar manner as in step 2 and check how the b...

Страница 70: ...ter hole of the air water valve with your finger and be sure that air comes out of the nozzle Release your finger from the hole and check that air does not come out of the nozzle 5 Be sure that endosc...

Страница 71: ...oon air feed outlet 3 7 5 Inspecting the Instrument Channel Insert an endotherapy device from the instrument channel inlet and check that the tip of endotherapy device comes smoothly out of the instru...

Страница 72: ...the distal end of the endoscope are not disengaged but remain fixed Look the distal end from an angle to check no dirt or foreign substances adhering to the objective lens Note Check that the objecti...

Страница 73: ...button on the light source to turn on the lamp and observe the endoscopic image on the monitor Check that image is clear and nothing obstructs endoscopic view Note If wiping does not remove cloudines...

Страница 74: ...ose an infection risk Do not use the TS 13101 Over tubes and BS 2 balloons on patients allergic to latex Doing so can create a risk of an anaphylactic reaction shock Do not supply an excessive amount...

Страница 75: ...may be damaged Do not bend the insertion portion near the control portion in a small radius It may cause the endoscope to malfunction When inserting or withdrawing the endoscope make sure that the bal...

Страница 76: ...Prepare the accessories and endotherapy devices etc to be used and a spare forceps valve as well 4 1 2 Pretreatment of the Patient Prepare the patient in the normal endoscopy regimen Chapter 4 Method...

Страница 77: ...e endoscope or Over tube with the balloon inflated It may damage to the walls of the digestive tract causing perforation Use of devices such as endoscopic enteroscopy overtubes may be associated with...

Страница 78: ...he duodenum as doing so may cause complications CAUTION Do not directly apply Xylocaine spray to the insertion portion It may cause deterioration of the outer surface Do not use olive oil as a lubrica...

Страница 79: ...tions a patient to lie on examining table in a proper position according to endoscopy procedures 3 Unlock the bending portion by turning the up down locking lever and the left right locking knob in th...

Страница 80: ...t apply Xylocaine spray olive oil or the like directly to the insertion portion 6 Insert the distal end of the endoscope from the oral cavity to the pharynx while observing the process Adjust the brig...

Страница 81: ...oscope When the Over tube is inserted into the body or the endoscope is pulled out from this position the tip of the Over tube touches the balloon 9 Feed air to inflate the balloon on the Over tube an...

Страница 82: ...ir to inflate the balloon on the Over tube and stabilize it within the body cavity intestinal tract 16 Repeat steps 10 through 15 to advance the endoscope 17 Steer the distal end of the endoscope to t...

Страница 83: ...rt the endoscope by locking the bending portion only in the left right direction and unlocking it in the up down direction 3 Switch on the power to the processor and turn on the lamp 4 Remove air from...

Страница 84: ...vity intestinal tract 7 Insert the Over tube into the body cavity intestinal tract along the endoscope to a point close to the balloon on the distal end of the endoscope Note There is a thick line ind...

Страница 85: ...Insert the endoscope 11 Feed air to inflate the balloon on the distal end of the endoscope and stabilize it within the body cavity intestinal tract 12 Remove air to deflate the balloon on the Over tub...

Страница 86: ...to the digestive tract The mucous membrane of the digestive tract will become clearly visible 17 Steer the distal end of the endoscope to the region of interest by turning the up down and left right a...

Страница 87: ...Lens or If the Image is Obscured If mucus adheres to the distal objective lens or if the image is obscured clean the surface of the lens by pressing the air water valve When cleaning is complete remov...

Страница 88: ...ion CAUTION If resistance is encountered while advancing a forceps or endotherapy device within the instrument channel stop and withdraw the forceps or endotherapy device Repeat again but do not apply...

Страница 89: ...from the body 2 Ensure that the up down and left right locking mechanisms are in the unlocked free F position 3 Using the angle knob straighten the bending section to its neutral position 4 Slowly wit...

Страница 90: ...202B1263075 5 Press the Lamp button on the light source to turn off the lamp Chapter 4 Method of Use 90 EI580BT_E2 10_202B1263075 indb 90 2015 08 12 16 20 47...

Страница 91: ...may pose an infection risk CAUTION Do not grasp the bending portion forcefully when removing the hood Over tube and balloon Doing so may damage the endoscope 4 5 1 Removing the Hood Only When Used Re...

Страница 92: ...oward the distal end of the endoscope to remove Note If the balloon is too slippery to be held cover the balloon with gauze for easier removal Note Dispose of the removed balloon Note Make sure to rem...

Страница 93: ...aning performed at bedside immediately after use of the endoscope Note For details on pre cleaning and removal of the endoscope refer to the Reprocessing Manual Reprocessing Manual Chapter 3 Pre clean...

Страница 94: ...et Note the video processor and the light source If an appropriate image does not appear even after resetting turn them off straighten the bending section to unlock release the angle knobs withdraw th...

Страница 95: ...setting turn them off straighten the bending section to unlock release the angle knobs withdraw the endoscope slowly from the patient and then contact your local FUJIFILM dealer 2 Set the brightness l...

Страница 96: ...video processor and the light source If an appropriate image does not appear even after resetting turn them off straighten the bending section to unlock release the angle knobs withdraw the endoscope...

Страница 97: ...he video processor and the light source If an appropriate image does not appear even after resetting and it is impossible to continue the examination turn them off straighten the bending section to un...

Страница 98: ...ent equipment to restore image output The endoscope is working properly 3 Connect the endoscope properly to the video processor 4 If the problem occurred during treatment Note 1 stop treatment and rem...

Страница 99: ...ater channel is damaged 1 After pulling out the endoscope from a patient clean the air water channel according to the specified procedures Reprocessing Manual 3 2 Wiping and 3 4 Cleaning Air Water Cha...

Страница 100: ...valve does not return to the original position 1 Foreign matters or blood have adhered to the suction valve 2 Suction valve is damaged 1 Disconnect the suction tube After pulling out endoscope detach...

Страница 101: ...The bending control mechanism is malfunctioning 1 Operate the left right and up down angulation locks to unlock them 2 Immediately stop using the endoscope Do not forcibly withdraw the endoscope from...

Страница 102: ...y deflate the balloon using a syringe slowly withdraw the endoscope and Over tube together and then replace the balloon and Over tube with new ones Clean and dry the balloon air feed channel as necess...

Страница 103: ...em Viewing direction Field of view Observation range mm Method of illumination Image size Distal end diameter mm Flexible portion diameter mm Maximum diameter of insertion portion mm Flex Note 1 Minim...

Страница 104: ...dew condensation 70 to 106 kPa within range of atmospheric pressure Storage Environment Temperature Humidity Pressure 10 to 40 C 30 to 85 RH no dew condensation 70 to 106 kPa within range of atmospher...

Страница 105: ...cleaning adapter FOV DV7 AW 603 SB 605 ST 01B ST 05B TY 06S WB7024FW WB11003FW CA 610 CA 611 CA 606 Air Leak Tester Optional Item Name Model Air leak tester LT 7F Compatible Endotherapy Devices Name M...

Страница 106: ...al function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electric equipment Radiated emissions CISPR 11 Class A This product is intended for use in me...

Страница 107: ...er quality should be that of a typical commercial or hospital Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 11 5V 218 5V dip For 0 5 cycle 92V 138V...

Страница 108: ...ith the requirements of EN 60601 1 2 2007 However electromagnetic interference may occur on this product under electromagnetic environment that exceeds its noise level Electromagnetic interference may...

Страница 109: ...his product will be repaired free of charge within warranty guidelines The warranty period for the endoscope excluding accessories is one year after date of purchase Note that the warranty is void in...

Страница 110: ...ectronic equipment By ensuring this product is disposed of correctly you will help prevent potential negative consequences to the environment and human health which could otherwise be caused by inappr...

Страница 111: ...r 20 Label for the year of manufacture 20 LCD monitor 31 33 Left right angulation knob 35 Left right angulation lock 35 LG connector 34 LG connector label 20 Light guide rod 34 Lock 42 43 M Mouthpiece...

Страница 112: ...in your country USA Fujifilm Medical Systems U S A Inc http www fujifilmendoscopy com 800 385 4666 Australia FUJIFILM Australia Pty Ltd http www fujifilm com au 1800 060 209 Asia FUJIFILM Singapore Pt...

Страница 113: ...202B1263075 113 EI580BT_E2 10_202B1263075 indb 113 2015 08 12 16 20 48...

Страница 114: ...12 1 0 E2 Printed in Japan FUJIFILM Europe GmbH Heesenstrasse 31 40549 Duesseldorf Germany FUJIFILM Corporation 26 30 Nishiazabu 2 chome Minato ku Tokyo 106 8620 Japan EI580BT_E2 10_202B1263075 indb 1...

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